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Science and the Law

Analytical Data in Support of Regulation in Health, Food and the Environment

This one-day symposium examined the interaction between legislation and the underlying science which supports legislation, both in the development and application/compliance phases. In particular, the use of analytical methods and data in the regulation of health, food, and the environment has a major impact on the drafting of new legislation and on the public debate that typically precedes any new legislation. Existing databases used by legislators and those responsible for implementing legislation were considered in each sector. In addition, consideration was given to the impact of science on the regulation of new areas, such as functional foods, and the appropriate fora for the regulator and regulated industry to discuss technical issues.

Consumers face a barrage of product claims each day. These claims create consumer expectation of safety and product performance and, assuming they are accurate, facilitate well informed choice. But increased scrutiny of claims, especially where the claim involves potential health outcomes, means that claim substantiation and the science behind it are more important than ever.

Speakers in the symposium said that greater collaboration is needed to ensure that product claims are based on the best available scientific evidence. “What we need is not science for science’s sake, but science for society’s sake,” said David Richardson. He also said that “regulators must ensure that any claims are based on the best available scientific evidence and using the best tools and methods available in order to ensure the highest standards for consumers, while at the same time fostering and advancing innovation in the products they regulate. This can only be achieved if all interested parties, whether they be NGOs, academics, regulators or industry scientists, are brought together to advance regulatory science and leverage its potential to promote and protect public health.”

Other speakers in the symposium discussed claims made in the realm of regulated products, ranging from the very familiar, health and nutritional claims on food, to the newer, less familiar territory of potential future claims around “modified risk” tobacco products, which according to the Family Smoking Prevention and Tobacco Control Act of 2009 (FSPTCA) also comes under the remit of the U.S. Food and Drug Administration (FDA). The FDA is currently the only regulator with a mandate to evaluate submissions to place modified risk tobacco products on the U.S. market.

David Richardson, a food scientist at Reading University in the UK, says that the use of claims in the food and dietary supplement market is widespread. But supermarket shelves may look very different as regulators crack down on false and misleading claims. In the European Union (EU) for example, regulation published in May this year (Regulation EC No 432/2012) concerning the well-established nutrient functions of vitamins and minerals could see hundreds of nutritional and health claims become illegal. The European Commission has published a list of more than 1600 unauthorized claims on the EU Register. All labels and commercial communications must comply with the regulation by 14th December 2012 following a six-month transitional period. The result, he says, is that we must achieve an important balancing act between overcoming challenges in generating and presenting scientific data to justify a claim and achieve conclusive evidence of cause and effect, while not reducing a company’s willingness to invest in new research and innovation or impacting international trade.

But whereas health claims on food and nutritional supplements are commonplace, the possibility of making reduced-risk claims is a new prospect for modified risk tobacco products which manufacturers might seek to place on the U.S. market. Under the FSPTCA, companies can apply to the FDA to market lower-risk tobacco products in the U.S. providing they provide scientific proof that marketing of the product will not only reduce harm to individual users, but also benefit the population as a whole. The FDA has started to draft guidance on the kind of scientific and other data needed to forecast and monitor a proposed modified risk tobacco product’s potential impact on public health, including: product characterization; the amount of human exposure to harmful constituents; perceptions about the product and effects on human health. “Right now, this is a very new area of science and there is a shortage of established regulatory science to help assess the health risks of modified-risk tobacco products,” says Christopher Proctor, Chief Scientific Officer at British American Tobacco. “We need reliable credible evidence to further this area of science and fill the gaps identified by the regulators. The FDA has set out a large number of research questions that they want answered in order to help them create the scientific underpinning to regulations, and it is going to take a considerable multi-disciplinary research effort, involving a range of research contributors, to complete the science they need.”

The sentiment was echoed by Rodger Curren, of the Institute for in vitro Sciences in the US, who said that transparency, data sharing, and active communication between scientists, industry and regulators is the best way to ensure the intelligent application of science to regulatory policy. Rodger described how such an approach was key to the successful use and acceptance of new in vitro ocular models for hazard testing of anti-microbial cleaning products. He said that this approach could be modeled for use in the safety assessment of other consumer products, thus supporting the 3Rs (reduce, reuse, and recycle) approach and avoiding new animal experimentation.

Among the other speakers, Istvan Pelczer (Frick Chemistry Laboratory, Princeton) discussed “Honey analysis by high-sensitivity cryo-13C-NMR” detection of the fraudulent production of honey possible by this technique.

Judith Currano (Chemistry Library, University of Pennsylvania) shared her thoughts on “Hunting and gathering: locating information on the cusp between science and legislation.” Her talk used a case study approach to examine methods of finding information on the science and legislation dealing with food, drugs, and the environment.

K. Scott Phillips (Division of Chemistry and Materials Science, FDA) presented research on contact lenses at FDA in a talk entitled “Contact lens materials and multipurpose solutions: lessons learned from laboratory research.” This talk discussed research efforts in the areas of materials chemistry and bioanalytical chemistry, the project's contribution to current regulatory science knowledge, and potential implications that the data have for public health.

Lucinda Buhse (Division of Pharmaceutical Analysis, FDA) enlightened us on “Rapid screening methods for pharmaceutical surveillance.” An ever-increasing percentage of products and ingredients is now coming from overseas, potentially increasing consumer exposure to poor quality, counterfeit, and adulterated pharmaceutical products. In response to this situation, the FDA has developed rapid and portable screening methods to assess the quality and safety of pharmaceutical products at ports of entry.

George Lunn (Office of New Drug Quality Assessment, FDA) informed us about “Analytical procedures and the regulation of new drug development.” The information that should be submitted to the FDA is governed by the Food, Drug, and Cosmetic Act, Title 21 of the Code of Federal Regulations, and various guidances. This talk focused on these requirements and recommendations.

Thomas Hartung (School of Public Health, Johns Hopkins University) described some ground breaking work on “Mapping the human toxome for new regulatory tools.” The lecture summarized the lessons learned from the development, validation and acceptance of alternative methods for the creation of a new approach for regulatory toxicology. Beside the technical development of new approaches, a case was made that we need conceptual steering, an objective assessment of current practices by evidence-based toxicology (modeled on evidence-based medicine), and implementation into legislation.

The session closed with a presentation from Frederick Stoss (Silverman Library, University at Buffalo - The State University of New York) entitled “Environmental databases: a trip down memory lane and new journeys in the 21st century.” This presentation compared the “environmental” content of several STEM bibliographic databases.